Cancer vaccine cuts melanoma recurrence risk as FDA expands treatment options

Moderna and Merck’s personalized mRNA cancer vaccine reduced melanoma recurrence risk by 42% compared with standard treatment. FDA decisions also expanded options for molecularly defined rectal cancer, chronic hepatitis B and HIV in newborns, while several trials reported gains in kidney-function preservation.

Key developments

Melanoma vaccine lowers recurrence risk

Moderna and Merck’s personalized mRNA cancer vaccine met key trial endpoints and reduced disease recurrence risk in patients with melanoma by 42% compared with standard treatment.

The result strengthens evidence that personalized mRNA vaccination can help prevent cancer from returning.

Oct 22 · STAT · CNN

New cancer approvals and durable immunotherapy results

The FDA granted accelerated approval to Jemperli for MSI-H/dMMR locally advanced rectal cancer and traditional approval to Keytruda for TMB-H solid tumors. Separately, none of 111 patients in NICHE-2’s primary efficacy population with locally advanced mismatch repair–deficient colon cancer had experienced recurrence after short-course immunotherapy before surgery; all were alive at their latest follow-up.

Molecular testing is defining both access to approved cancer treatments and the patient groups showing durable immunotherapy outcomes.

Oct 19–22 · Pharmaceutical Executive · Cure Today · Medical Xpress

Hepatitis B combination treatment approved

The FDA approved Hibsago (bepirovirsen) injection alongside existing antiviral therapy for certain adults with chronic hepatitis B who do not have cirrhosis.

Eligible adults gain another treatment option, but the approval does not extend to patients with cirrhosis or use on its own.

Oct 20 · FDA Press

HIV treatment reaches newborns

The FDA approved dolutegravir for treating HIV-1 in newborns, informed by an international IMPAACT Network study that established an effective dosing regimen for full-term newborns.

Newborn-specific dosing evidence supports HIV treatment from the earliest stage of life.

Oct 22 · Medical Xpress · News-Medical

Hospital glucose meters face highest-risk recall

Nova Biomedical is removing certain StatStrip Glucose Hospital Meter Systems from use or sale. The FDA assigned its most serious recall classification, warning that continued use may cause serious injury or death.

Affected hospital glucose meters pose a direct patient-safety risk if they remain in use.

Oct 20 · CDRH New - News and Updates | FDA

Two IgA therapies preserve kidney function

Sibeprenlimab stabilized the estimated glomerular filtration rate slope over 24 months in a randomized phase 3 IgA nephropathy trial. A separate final phase 3 analysis found that atacicept slowed and stabilized kidney-function decline compared with placebo.

Both results provide evidence on preserving kidney function rather than only changing a shorter-term disease marker.

Oct 22 · The New England Journal of Medicine · The New England Journal of Medicine

Breast radiation course shortened

The national RT CHARM trial found that three weeks of radiation after mastectomy was as safe and effective as the standard five-week course for women undergoing breast reconstruction.

A shorter course could reduce treatment visits without compromising safety or effectiveness.

Oct 21 · Medical Xpress

Pancreatic cancer survival benefit spans subgroups

A phase 3 analysis found that daraxonrasib improved survival versus standard chemotherapy across multiple advanced pancreatic cancer subgroups, including different RAS mutations and patients without an identified RAS mutation.

The survival benefit may extend beyond a single mutation-defined patient group.

Oct 23 · Medical Xpress

Retatrutide improves sleep apnea

Once-weekly retatrutide reduced the apnea–hypopnea index more than placebo in two trials involving people with obstructive sleep apnea and obesity or overweight, with or without type 2 diabetes.

The findings support a potential drug treatment for sleep apnea in people with excess weight.

Oct 21 · The New England Journal of Medicine

Ebola spreads as vaccine testing begins

Nigeria confirmed an imported Ebola case linked to the outbreak centered in the Democratic Republic of the Congo, becoming the fifth country to identify a related infection. The first Ebola vaccine clinical trial in the current outbreak also began.

A potential prevention tool is entering testing while outbreak-linked infections cross national borders.

Oct 21–24 · STAT · Medical Xpress

Also this week

Cancer and safety

• Tango Therapeutics reported tumor responses in 82% of patients with a certain type of advanced pancreatic cancer receiving an experimental drug combination. STAT · STAT

• Divarasib improved survival compared with sotorasib or adagrasib in KRAS G12C-positive non-small cell lung cancer. CancerNetwork

• Invikafusp alfa showed early activity in the phase 1/2 START-001 trial, largely involving patients with checkpoint-inhibitor-resistant solid tumors, with an accompanying release reporting halted progression in refractory tumors. News Releases · Nature (Nature Medicine)

• An analysis found that most cancer medicines approved by European regulators over a recent four-year period did not offer high clinical benefit. STAT

• Over half of highly frail older, long-term breast cancer survivors received no Medicare home health care in a given year, according to a study. Medical Xpress

• A patient died in a Bristol Myers Squibb trial of CAR-T therapy for autoimmune disease, with a causal link to treatment not established. STAT

Immune and kidney

• Ravulizumab reduced proteinuria significantly more than placebo in an interim analysis of a randomized phase 3 trial in adults with IgA nephropathy. The New England Journal of Medicine

• Tegoprubart preserved kidney function better than tacrolimus in the phase 2 BESTOW trial of adults receiving their first kidney transplant. Medical Xpress

• GLP-1 receptor agonist use was associated with lower risks of dialysis or kidney transplantation in adults with bipolar disorder and chronic kidney disease. Medical Xpress

• Half-matched family-donor bone marrow transplants achieved 96% survival among children, adolescents and young adults with severe aplastic anemia. Medical Xpress

• Gilead Sciences reported that an oral treatment eliminated symptoms in patients with a type of inflammatory bowel disease in a mid-stage study. STAT

• Once-daily oral icotrokinra produced clinical responses at week 12 significantly more often than placebo in moderately to severely active ulcerative colitis. Medical Xpress

• Roivant reported positive trials of an immune drug in non-infectious uveitis. STAT

Neurology and psychiatry

• A Novartis multiple sclerosis treatment reduced relapse rates by one-third compared with a standard treatment in pivotal trials. STAT

• A newly FDA-cleared PTSD treatment combining personalized brain mapping with magnetic stimulation reported a 52% symptom reduction and 68% remission in a clinical trial. Top Health News -- ScienceDaily

• A Columbia-led clinical trial found that opening blocked carotid arteries with stenting or surgery did not improve cognition. Medical Xpress

• Anticoagulant use was associated with lower ischemic stroke and death risks in people with atrial fibrillation and previous intracranial hemorrhage, while newer anticoagulants were not associated with more recurrent brain bleeds. Medical Xpress

• Blocking immune cells involved in neuronal destruction preserved roughly 40% more tissue in memory centers and improved memory in mice without removing tau buildup. Top Health News -- ScienceDaily

• Low-dose aspirin use was associated with a 70% lower relative dementia risk in older adults with a specific genetic profile, a subgroup finding rather than evidence of general protection. Top Health News -- ScienceDaily

Prevention and treatment

• A modeling study projected substantially more chronic hepatitis B infections among U.S. children if universal birth vaccination were replaced by delayed vaccination or shared decision-making. Medical Xpress · Time Magazine

• The FDA approved the first generic of Climara Pro, a once-weekly estradiol and levonorgestrel hormone patch for women with an intact uterus. FDA Press

• Low-dose prednisolone modestly eased long-COVID symptoms in a phase 3 trial, while B vitamins showed no benefit. Bioengineer.org

• An analysis of more than 91,000 people linked consistent blood-pressure medication use to an 11% reduction in major cardiovascular events, with little or no measurable benefit among those missing too many doses. Top Health News -- ScienceDaily

• A study associated two alcoholic drinks daily with a 1-in-25 lifetime risk of alcohol-related death and found no significant overall health benefits from alcohol. Top Health News -- ScienceDaily

Disease mechanisms

• Researchers identified five biological subtypes of fatty liver disease with differing risks of liver failure, cancer, heart disease and other serious complications. Top Health News -- ScienceDaily

• Advanced imaging showed that statins can attach to a muscle-cell protein and force open a calcium-regulating channel, offering a possible mechanism for muscle damage. Top Health News -- ScienceDaily

• Blood antibody patterns were associated with Crohn’s disease or ulcerative colitis up to 10 years before diagnosis and distinguished people at risk of more complicated disease. Top Health News -- ScienceDaily

What to watch

• Results from the newly begun Ebola vaccine trial during the Democratic Republic of the Congo outbreak; timing has not been announced.

• Further safety findings following the death in Bristol Myers Squibb’s autoimmune CAR-T trial, including whether treatment contributed; timing has not been announced.

• The final outcome of the ravulizumab phase 3 IgA nephropathy trial following its interim proteinuria result; timing has not been announced.